Drugs made in Canada and abroad must meet high safety and quality standards before they can be sold to Canadians. To ensure compliance, Health Canada licenses and inspects companies that fabricate, package, test, import, distribute, and wholesale drugs sold to Canadians. As part of its initiative to increase overall regulatory openness and transparency, Health Canada has launched a searchable public database of site inspections, which provides information on inspections conducted since 2012.1
What you need to know
- The Drug and Health Product Inspections Database is designed to provide ready access to information on inspections of domestic and foreign companies that manufacture and sell drug products in the Canadian market. Previously, this information was only available through an Access to Information request.
- The purpose of the Database is to provide the public with timely, plain-language information on inspections.
- The database will indicate whether a site was given a "Compliant" or "Non-Compliant" rating, and whether any conditions were imposed on the site’s licence as result of the inspection.
- For sites found to be Non-Compliant, the database will provide details on the observations and deficiencies noted by the inspector, and measures proposed and/or taken by Health Canada as a result of the Non-Compliant rating.
- Paper-review and on-site inspections of facilities are conducted in foreign countries by Health Canada, and these foreign inspections will be listed in the database.
Note that Health Canada also publishes an Inspection Tracker that provides a "snapshot" of emerging issues and actions undertaken as part of the inspection process.2 The Tracker is regularly updated and current actions being taken by Health Canada include request for voluntary quarantine, stop sales, import restrictions and product recalls.
For more information on the applicability of the database to your business or to discuss the inspection process, please contact the authors.
* With assistance from Kaitlin Soye, articling student.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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